Autologous Bronchial Basal Cell Transplantation for Treatment of COPD


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Verified June 2017 by Xiaotian Dai, Regend Therapeutics

Sponsor:

Collaborators:

Southwest Hospital, China

Tongji University

Information provided by (Responsible Party):

Xiaotian Dai, Regend Therapeutics

ClinicalTrials.gov Identifier:

NCT03188627

First received: June 13, 2017

Last updated: June 13, 2017

Last verified: June 2017

Chronic Obstructive Pulmonary Disease (COPD) is usually characterized by long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. For COPD patients, pulmonary bronchus structures are damaged and cannot be repaired by recent clinical methods so far. This study intends to carry out a single-centered and non-randomized phase I/II clinical trial with concurrent controls to investigate whether bronchial basal cells can regenerate damaged lung tissue. During the treatment, bronchial basal cells will be isolated from patients’ own bronchi and expanded in vitro. After careful characterization, expanded cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. The safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.

Chronic Obstructive Pulmonary Disease Biological: Bronchial basal cells Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Single-centered, Non-randomized, Concurrent Control Study on Autologous Bronchial Basal Cell Transplantation for Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Primary Outcome Measures:

  • Forced expiratory volume in one second (FEV1) [ Time Frame: 1-6 months ]

    One of the indicators in pulmonary function test, a marker to assess airway obstruction

  • Forced vital capacity (FVC) [ Time Frame: 1-6 months ]

    One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation

Secondary Outcome Measures:

  • The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) [ Time Frame: 1-6 months ]

    One of the indicators in pulmonary function test, representing the proportion of a person’s vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity

  • Maximum mid-expiratory flow (MMF) [ Time Frame: 1-6 months ]

    One of the indicators in pulmonary function test, standing for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second

  • Maximum voluntary ventilation (MVV) [ Time Frame: 1-6 months ]

    One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute

  • Diffusion capacity of CO (DLCO) [ Time Frame: 1-6 months ]

    One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood

  • 6-minute-walk test (6MWT) [ Time Frame: 1-6 months ]

    An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases

  • Modified medical research council (MMRC) chronic dyspnea scale [ Time Frame: 1-6 months ]

    An indicator to evaluate the level of dyspnea

  • St. George’s respiratory questionnaire (SGRQ) scale [ Time Frame: 1-6 months ]

    A questionnaire to assess life quality affected by the respiratory problems

  • Imaging of lung by high resolution computed tomography (HR-CT) [ Time Frame: 1-6 months ]

    HR-CT images of lung will be analyzed to indicate the pulmonary structure.

Estimated Enrollment: 20
Actual Study Start Date: May 19, 2017
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: February 18, 2019 (Final data collection date for primary outcome measure)
Experimental: Bronchial basal cells

Transplantation of autologous bronchial basal cells

Biological: Bronchial basal cells

Transplantation of autologous bronchial basal cells

No Intervention: Control

Conventional treatment

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged between 40 to 75;
  • Diagnosed with COPD according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by FEV1<70% predicted value and FEV1/FVC < 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by CT or blood examination.);
  • Current smoker or ex-smoker with a history of no less than 10 years or 10 packs/year;
  • Tolerant to bronchofiberscope;
  • Written informed consent signed.

Exclusion Criteria:

  • Pregnant or lactating women;
  • Patients positive for syphilis, HIV;
  • Patients with malignant tumor;
  • Patients with serious significant pulmonary infection and need anti-infection treatment;
  • Patients with serious heart disease(NYHA class Ⅲ-Ⅳ);
  • Patients with a history of abusing alcohol and illicit drug;
  • Patients participated in other clinical trials in the past 3 months;
  • Patients assessed as inappropriate to participate in this clinical trial by investigator.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03188627

First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing, China, 400038
Contact: Xiaotian Dai, M.D.    86-23-68765681    daixt1973@163.com   
Contact: Wei Zuo, Ph.D.    86-10-65985082    zuow@regend.cn   
Sub-Investigator: Ting Zhang, Ph.D.         
Sub-Investigator: Yu Ma, Ph.D.         

Regend Therapeutics

Southwest Hospital, China

Tongji University

Publications:

Responsible Party: Xiaotian Dai, principal investigator, Regend Therapeutics
ClinicalTrials.gov Identifier: NCT03188627     History of Changes
Other Study ID Numbers: 20170206
Study First Received: June 13, 2017
Last Updated: June 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 15, 2017